# K983712: Amplaid A311 Series

- Pathway: 510(k) (Traditional)
- Applicant: Amplifon S.P.A.
- Decided: Jan 12, 1999 after 83 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880059 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880059: Amplaid 309 Clinical Audiometer, Amplus Corp. (1988) Summary page 1.
- K891988: Amplaid A308 Clinical Audiometer, Amplus Corp. (1989) Summary page 1.
- K971747: Amplaid 460, Amplifon S.P.A. (1997) Summary page 1.

## Indications for use
The Amplaid A311 Series is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Source page: https://510kreport.com/device/K983712
Methodology: https://510kreport.com/methodology